Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
FDA device recall Z-0260-2024 · posted 2023-11-07 · Open, Classified
Recall details
- Recalling firm
- Alcon Research, LLC
- Reason for recall
- Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
- Action taken
- On September 7, 2023, Alcon contacted consignees by phone to notify them of the recall. Alcon asked consignees to take the following action: 1. Discontinue using the affected lot and requested the customer confirm any quantity of remaining units in order to start the return process for any unused custom paks.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 120 packs
- Distribution
- US: VA OUS: None
- Date initiated
- 2023-09-07
- Date posted
- 2023-11-07
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALCON SURGICAL PROCEDURE PACKS (K880961) | Alcon Laboratories | 1988-04-29 |